Adverse drug reactions in topically applied drugs

Topical drugs, such as non-steroidal anti-inflammatory drugs (NSAIDs), are available without prescription and are widely used for moderate, acute and chronique painful conditions. However, the different characteristics of the ir adverse reactions remain largely unknown. The present work was undertake n in order to quantify ADRs reported to our centre with topical drugs durin g a period of 5 years. The retrospective study was performed using the spon taneous reports to the Midi-Pyrenees Pharmacovigilance Centre from 1993 to 1997. The following routes of administration were selected: cutaneous, ocul ar, pulmonar, vaginal; intra-articular, auricular, nasal, buccal and pharyn geal. One hundred and twenty-eight notifications were found in the database . Thirty-eight cases (29.7 per cent) were between 60 and 75 pars old, 25 ca ses (19.5 per cent) between 45 and 60 years old and 22 cases (17.2 per cent ) between 30 and 45 years old. The most frequently reported ADRs were cutan eous (n=71, 55.5 per cent) cardiovascular (n=16, 12.5 per cent), ocular (n= 13, 10.2 per cent), neurological (n=12, 9.4 per cent) and oro-pharyngeal (n =7, 5.4 per cent). Systemic ADRs (45 cases, 35 per cent) occurred mainly wi th aerosols (n=10) and patches (n=6). Twenty-seven reports (21 per cent) we re classified as 'serious' including one death (misuse). The main pharmacot herapeutic agents involved were rheumatological [(n=29) including 20 NSAIDs ], dermatological (n=27), ophthalmological (n=16), pneumological (n=15) and cardiovascular (n=15) drugs. In 21 cases the rechallenge was positive. In eight cases (6.3 per cent), ADRs occurred after self-medication. This study underlines the importance of monitoring ADRs of topical drugs. The serious ness of such ADRs and the occurrence of systemic effects with such drugs se ems rather frequent (as shown by topical NSAIDs-induced photosensidization) .